A randomized trial of an educational intervention in type 2 diabetes patients

2 型糖尿病患者教育干预的随机试验

• 批准号: 8398542
• 负责人: Howard S. Gordon
• 金额: --
• 依托单位: JESSE BROWN VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8398542
• 关键词: Adherence; Adopted; Affect; Age; Amputation; Area; Attention; Behavior; Belief; Blindness; Cardiovascular Diseases; Caring; Characteristics; Chronic; Clinic; Clinical; Communication; Consultations; Control Locus; Cost Analysis; Decision Making; Diabetes Mellitus; Disease; Educational Intervention; Educational process of instructing; Effectiveness; End stage renal failure; Environment; Evaluation; Focus Groups; Funding; Gender; Goals; Habits; Health; Healthcare; Human Resources; Intervention; Intervention Trial; Knowledge; Lead; Mediating; Mediator of activation protein; Medical; Methodology; Methods; Minority Groups; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Patient Care; Patient Participation; Patient Self-Report; Patient-Centered Care; Patients; Persons; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Play; Preparation; Prevalence; Primary Care Physician; Quality of Care; Race; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Regimen; Reporting; Research; Research Design; Role; Self Efficacy; Site; Testing; Training; Training Programs; Trust; Veterans; Visit; Work; base; communication behavior; cost; design; diabetes control; diabetic; diet and exercise; experience; health literacy; improved; innovation; lifestyle factors; literacy; medication compliance; patient oriented; post intervention; racial and ethnic; randomized trial; skills training; success; therapy design

DESCRIPTION (provided by applicant): Background: Diabetes is estimated to affect up to 1 in 5 VA patients overall and up to 1 in 4 racial/ethnic minority patients. Patients with low health literacy and minority groups have more difficulty communicating with physicians, report lower adherence to physicians' recommendations, and have higher rates of poor diabetes outcomes. Activating patients to use more effective communication with physicians' can lead to better adherence to treatment and to better biomedical outcomes. In this project we build upon our prior work from two HSRD funded pilot projects to improve doctor patient communication in patients with type 2 diabetes mellitus (T2DM). In a previously funded short-term project, SHP-08-182, we conducted focus groups with patients with T2DM to elicit and understand from the patient perspective, barriers to communicating with their physician. This qualitative work was used in a subsequent pilot project, PPO-08-402 to refine and pilot test an educational video to encourage patients to use active participatory communication in their visits to physicians. This work was successfully completed and the product is a 10 minute video that in testing was found to be acceptable to patients and feasible for patients to view immediately preceding their medical encounter. Objectives: In this project we propose to test the effectiveness of the video as an intervention to improved patients' communication. Our primary aim is to conduct a randomized controlled trial of an intervention testing whether the intervention increases patients' active participatory communication behaviors, patients' post-visit ratings of self efficacy to communicate, medication adherence, and diabetic control (HgbA1c). There are four secondary aims which include assessments of the (1) mediators, and (2) moderators of the relationship of the intervention condition to outcomes, (3) costs of the intervention, and (4) an evaluation of the feasibility of using the video for pre-visit preparation. Methods: We will conduct a two group, pre-post, randomized controlled, single-site trial of the intervention in patients with T2DM. We will recruit 156 patients and their physicians for a pre and post-intervention visit. Physicians will be trained with the agenda setting module from the Four Habits model. Patients will be randomized to view a 10 minute intervention or control video prior to their second visit. Visits will be audio recorde and analyzed for patients' and physicians' communication behaviors. Self-efficacy to communicate will be collected by self report. Adherence will be collected by self-report and by medication possession ratio. Diabetic control is collected by chart review. Analyses will evaluate the relationship of the intervention condition to outcomes, mediators and moderators of that relationship, and will estimate costs of the intervention and feasibility of using the video in a busy clinic. Impacts: VA transformation efforts including interprofessional Patient Aligned Care Teams (PACT) are focusing attention on patient-centered care. Improved communication is a central feature of patient centered care. Communication in medical interactions is critical and plays an important, but often overlooked role in health-care decision making and quality of care. Patients who have difficulty communicating are less involved in consultations with their physician, receive less information and support, and are less satisfied with their care. In turn, these patients may not understand their treatment options, may have less knowledge, less positive beliefs about treatment and less trust in physician, and may experience poorer health outcomes. Teaching patients to communicate more effectively is patient-centered because it inherently supports a patient-driven approach to delivering healthcare. Our intervention is designed to encourage patients' active communication. Improving patients' communication is a unique focus that may supplement and add to the VA efforts in areas such as the Patient Aligned Care Team. In addition, the methodology is not disease specific and may be a paradigm for improvement in other conditions.

描述（由申请人提供）： 背景：据估计，糖尿病影响多达1/5的VA患者，以及多达1/4的少数种族/民族患者。健康素养低的患者和少数群体与医生沟通更困难，对医生建议的依从性较低，糖尿病预后不良的比例较高。激活患者使用更有效的沟通与医生的可以导致更好的坚持治疗和更好的生物医学结果。在这个项目中，我们建立在我们以前的工作，从两个HSRD资助的试点项目，以改善2型糖尿病（T2 DM）患者的医患沟通。在之前资助的短期项目SHP-08-182中，我们对T2 DM患者进行了焦点小组，从患者的角度引出并了解与医生沟通的障碍。这一定性工作被用于随后的试点项目PPO-08-402，以完善和试点测试教育视频，鼓励患者在就诊时使用积极的参与式沟通。这项工作已成功完成，该产品是一个10分钟的视频，在测试中被发现是可接受的患者和可行的患者查看之前立即他们的医疗遭遇。目的：在这个项目中，我们建议测试视频作为干预的有效性， 改善患者沟通。我们的主要目的是进行一项干预的随机对照试验，测试干预是否增加了患者的积极参与性沟通行为，患者的自我效能评估，药物依从性和糖尿病控制（HbA 1c）。有四个次要目标，包括评估（1）调解人，（2）干预条件与结果关系的主持人，（3）干预成本，以及（4）评估使用视频进行访视前准备的可行性。方法：我们将对2型糖尿病患者进行两组、前后、随机对照、单中心的干预试验。我们将招募 对156名患者及其医生进行干预前后访视。医生将接受培训 用四个习惯模型中的议程设置模块。患者将在第二次访视前随机观看10分钟的干预或对照视频。访视将被录音并分析患者和医生的沟通行为。沟通自我效能将通过自我报告收集。依从性将通过自我报告和药物拥有率收集。通过病历审查收集糖尿病控制。分析将评估干预条件与结果的关系，该关系的中介者和调节者，并将估计干预的成本和在忙碌诊所中使用视频的可行性。影响：VA转型工作，包括跨专业的患者对齐护理团队（PACT）正在关注以患者为中心的护理。改善沟通是以患者为中心的护理的核心特征。医疗互动中的沟通至关重要，在医疗决策和护理质量方面发挥着重要但往往被忽视的作用。沟通困难的患者较少参与与医生的协商，获得的信息和支持较少，对他们的护理不太满意。反过来，这些患者可能不了解他们的治疗选择，可能对治疗的知识较少，对治疗的积极信念较少，对医生的信任较少，并且可能经历更差的健康结果。教患者更有效地沟通是以患者为中心的，因为它本质上支持以患者为导向的医疗保健方法。我们的干预旨在鼓励患者积极沟通。改善患者的沟通是一个独特的重点，可以补充和增加VA的努力领域，如患者对齐的护理团队。此外，该方法不是疾病特异性的，可能是改善其他条件的范例。